Attachment 7 - QASP_Biohazard Waste Removal WRSU.pdf

QUALITY ASSURANCE SURVEILLANCE

PLAN (QASP)

Biohazard Waste Management Services Whiteriver Service Unit (WRSU) Whiteriver, Arizona

1. Purpose This Quality Assurance Surveillance Plan (QASP) defines the Government’s approach to monitoring and evaluating Contractor performance for biohazard (regulated medical) waste management services at the Whiteriver Service Unit (WRSU), ensuring compliance with the Performance Work Statement (PWS), applicable federal and Arizona regulations, and Indian Health Service (IHS) policies.

2. Scope This QASP applies to all biohazard waste management services performed at WRSU facilities, including:

• Hospital and outpatient clinics

• Ancillary departments (laboratory, pharmacy, dental, radiology)

• Collection, packaging, labeling, storage, transportation, treatment, and disposal

• Documentation and regulatory reporting

Contract No.: TBD

3. Applicable Standards and Regulations Performance will be evaluated against, at a minimum:

• OSHA – 29 CFR 1910 (Bloodborne Pathogens)

• EPA / RCRA regulations

• DOT – 49 CFR Hazardous Materials Regulations

• Arizona Department of Environmental Quality (ADEQ) requirements

• CDC infection control guidance

• IHS policies and WRSU local SOPs

4. Roles and Responsibilities

4.1 Contracting Officer (CO)

• Overall authority for contract administration

• Approves contractual remedies and modifications

4.2 Contracting Officer’s Representative (COR)

• Conducts routine and incident-based surveillance

• Documents compliance and deficiencies

• Coordinates with WRSU Infection Control, Safety, and Environmental staff

• Reports performance issues to the CO

4.3 WRSU Facility Stakeholders

• Infection Prevention & Control

• Safety Officer

• Environmental Services (EVS)

• Clinical Department Representatives

Provide technical input and report observed deficiencies or incidents.

5. Performance Surveillance Approach The Government will use a risk-based, performance-oriented surveillance approach, with emphasis on:

• Infection prevention

• Regulatory compliance

• Patient, staff, and contractor safety

• Environmental protection

Due to WRSU’s remote location, special attention will be given to:

• Pickup reliability and contingency planning

• Storage capacity and conditions

• Documentation accuracy during extended transport timelines

Surveillance intensity may increase following incidents, missed pickups, or regulatory concerns.

6. Performance Objectives, Standards, and Surveillance Methods

Performance Objective

Performance Standard (AQL)

Surveillance Method Frequency Responsible

Party Proper waste segregation 100% compliance Visual inspection Weekly COR / Infection

Control Timely waste pickup

No missed or delayed pickups

Schedule & log review Weekly COR

Safe handling & transport

Zero spills, exposures, or violations

Observation & incident review Monthly COR / Safety

Officer Proper labeling & packaging

100% compliant containers Random sampling Monthly COR

Regulatory documentation

Complete, accurate manifests Document review Monthly COR

Contractor staff training

All certifications current Records review Quarterly COR

7. Surveillance Methods

7.1 Visual Inspections

On-site inspections of:

• Biohazard containers

• Storage rooms and external holding areas

• PPE usage and handling practices

7.2 Document Reviews

Review of:

• Waste manifests and chain-of-custody records

• Disposal/treatment certificates

• Training and certification records

• Incident and spill reports

7.3 Random Sampling

Random inspections of containers and documentation to identify trends and systemic issues.

7.4 Incident-Based Surveillance

Immediate review following:

• Spills or leaks

• Exposure incidents

• Missed pickups

• Regulatory citations or near misses

8. Performance Documentation Performance results will be documented using:

• COR inspection checklists

• Surveillance logs

• Corrective action tracking logs

• Email correspondence

• Monthly performance summaries

Records will be retained per IHS and HHS records management requirements.

9. Deficiencies and Corrective Actions When performance does not meet standards:

1. COR documents the deficiency

2. Contractor is notified in writing

3. Contractor submits a Corrective Action Plan (CAP)

4. Increased surveillance may be implemented

5. CO determines contractual remedies if deficiencies persist

Immediate corrective action is required for any safety or regulatory violation.

10. Incentives and Remedies Performance outcomes may be used to:

• Support CPARS evaluations

• Justify award fee or incentive determinations (if applicable)

• Support contractual remedies for continued non-performance

11. CPARS Support Surveillance data collected under this QASP will support CPARS ratings, with emphasis on:

• Quality

• Schedule reliability (critical for remote service delivery)

• Regulatory compliance

• Safety

12. QASP Review and Updates This QASP may be updated as necessary to reflect:

• Changes in WRSU operations

• Regulatory updates

• Contract modifications

• Contractor performance trends

All updates will be coordinated with the CO.

Optional Attachments (Highly Recommended for WRSU)

• Biohazard Waste Inspection Checklist (Clinic & Hospital)

• PWS–QASP Crosswalk Matrix

• Spill / Exposure Incident Review Form

• Pickup Schedule & Contingency Plan